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Presented by Viatris: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim | Presented by Viatris | With Susannah Luthi, Emily Martin, Lauren Morello and Caitlin Oprysko. | | | — House Democrats push drug pricing legislation. — FDA inspection of Emergent casts doubt on J&J vaccine manufacturing. — Messonnier reassigned from CDC vaccine task force. It’s Friday, welcome back to Prescription Pulse. Spotted: Former FDA Commissioner Scott Gottlieb talking to his hometown Westport Magazine on Instagram Live on Thursday afternoon. As always, send tips to David Lim (dlim@politico.com or @davidalim). | | | | A message from Viatris: No matter where they are in the world, or where they are in life, Viatris is committed to providing patients the quality, affordable medications they need on their journey to better health. Learn more about Viatris. | | | | | | HOUSE DEMOCRATS MOVE ON DRUG PRICE NEGOTIATION — House Speaker Nancy Pelosi vowed that she’ll push sweeping drug price reform as part of Democrats’ forthcoming infrastructure extravaganza, as frustration over the Biden administration’s silence on the issue reached a boiling point on Capitol Hill this week. “Lowering health costs and prescription drug prices will be a top priority for House Democrats to be included in the American Families Plan,” Pelosi said Thursday as she reintroduced House Democrats’ drug price negotiation bill, which passed last Congress as H.R. 3 (116). The House Energy and Commerce Committee moved to plant the flag on a longtime Democratic priority as reports and rumors circulated that the White House is abandoning any substantive push on health care in the infrastructure plan. These reports mobilized Democrats and their allies, spurring a flurry of calls between key legislative staff on the Hill and the White House that didn’t clear things up as administration officials declined to say whether health proposals were in or out of the plan Biden is slated to preview next week. The friction shows a fundamental disagreement over the political stakes. Congressional Democrats see a failure to deliver on promises to overhaul drug pricing as a problem in the 2022 midterms, with seniors likely to be strongly represented among voters. Meanwhile, some in Biden world are wary about bogging down an already massive infrastructure investment delivering economic benefits with a fraught health care debate that will mobilize a powerful industry. “Health care is complicated politically and substantively,” said one adviser familiar with the administration’s deliberations. “It seems the White House doesn’t want to weigh down issues like preschool or college with lobbying campaigns from Big Pharma.” | | | | SUBSCRIBE TO “THE RECAST” TO JOIN AN IMPORTANT CONVERSATION : Power dynamics are changing in Washington and across the country. More people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. Our twice-weekly newsletter “The Recast” breaks down how race and identity shape politics and policy in America, and we are recasting how we report on it. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear critical new voices that challenge business as usual. Don’t miss out, SUBSCRIBE . Thank you to our sponsor, Intel. | | | | | | | | J&J’s VACCINE DRAMA CONTINUES — The Biden administration has stood by Johnson & Johnson as the vaccine maker struggled to deliver promised doses of its Covid-19 vaccine — but privately, frustrated senior health officials have largely written off the shot, seven people with knowledge of the matter told Erin Banco, Adam Cancryn and Sarah Owermohle. Johnson & Johnson, which has a long history of successful vaccine development, was one of the government’s first and biggest bets in the coronavirus vaccine race. But the company has faced a series of setbacks, including a contractor mix-up that ruined 15 million doses and revealed serious safety and hygiene lapses, and concerns that the vaccine may be linked to recent reports of rare, severe blood clots. A CDC vaccine advisory committee will meet Friday for the second time to review those concerns, and federal health officials are expected to update their current recommendation to pause use of the shot. But the Biden administration is bracing for yet another potential complication: If ongoing tests of remaining vaccine batches made by J&J’s contractor Emergent BioSolutions reveal further contamination, it could take the vaccine maker up to four months to replace those doses through manufacturing at alternate facilities, according to two people with direct knowledge of the situation. FDA INSPECTION OF EMERGENT CASTS DOUBT ON J&J PRODUCTION — Emergent BioSolutions’ vaccine plant in Baltimore is not large or sanitary enough, and the company hasn’t yet resolved issues that led to the contamination of millions of J&J doses, according to findings from a recent weeklong FDA inspection released Wednesday. Emergent said it is working with the FDA and J&J to resolve the issues quickly. "While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them," the company said in a statement. MESSONNIER REASSIGNED FROM CDC VACCINE TASK FORCE — CDC respiratory disease chief Nancy Messonnier has been reassigned from her position heading the agency's Covid-19 vaccine task force to an incident management response team headed by Director Rochelle Walensky, according to three people familiar with the move. Messonnier remains the top respiratory disease official at the CDC and is still employed by the agency, a CDC spokesperson said. But three people with knowledge of the situation told POLITICO she has since taken leave, and some of them characterized it as an unplanned vacation, Sarah Owermohle, Erin Banco and Adam Cancryn reported Thursday. Messonnier has not yet responded to a request for comment. VACCINE PATENT PROPOSAL STALLS — Members of the World Trade Organization are deadlocked on a proposal to suspend intellectual property rights on coronavirus medical products so that less-wealthy countries can develop life-saving vaccines and other goods on their own, POLITICO EU’s Ashleigh Furlong and Sarah Anne Aarup report. But the proposal, pitched by South Africa and India at the WTO, is still gaining traction politically as the gap in vaccination rates between rich and poor countries grows by the day. Meanwhile, manufacturers have struggled to keep up with demand. BY THE NUMBERS: 200M SHOTS ADMINISTERED — President Joe Biden on Wednesday said the U.S. has administered 200 million coronavirus shots. More than 34 percent of American adults are now fully vaccinated and at least 52 percent have received at least one dose of vaccine, according to CDC data. | | | FDA PLEDGES TO IMPLEMENT REGENERATIVE MEDICINE REGS — The FDA pledged Wednesday to end its policy of enforcement discretion of premarket approval requirements for certain regenerative medicine products at the end of May. “Despite all of the FDA’s efforts to engage industry, there continues to be broad marketing of these unapproved products for the treatment or cure of a wide range of diseases or medical conditions,” CBER Director Peter Marks wrote in a blog post. “Many of these unapproved products appear to be HCT/Ps that are regulated as drugs, devices and/or biological products subject to premarket approval requirements.” | | | | CHECK OUT FDA TODAY: Daily regulatory developments, sent directly to your inbox. AgencyIQ's daily newsletter, FDA Today, provides readers with actionable and insightful explanations of the latest FDA developments impacting the life sciences industry. Sign up for free today. | | | | | | | | HOSPITALS LOBBY BECERRA OVER 340B DISCOUNTS — Six associations, including the American Hospital Association and the Children’s Hospital Association, are asking HHS Secretary Xavier Becerra to take action against drug companies denying 340B discounts on brand drugs sold to hospitals. “HHS has the tools to address this illegal behavior,” the groups wrote Tuesday. “To that end, we are respectfully requesting that HHS immediately and definitively state that these refusals to provide discounts are illegal and take the action Congress specifically prescribed to address this type of situation — impose civil money penalties.” | | | ILLINOIS LAWMAKERS WANT EPA ACTION ON EtO — Democratic Illinois Reps. Brad Schneider, Bill Foster, Lauren Underwood and Marie Newman on Tuesday urged the Biden administration’s EPA to guarantee federal monitoring of ethylene oxide emissions from medical device sterilization facilities. The call comes weeks after an OIG report that found the Trump administration delayed the release of monitoring data from a Chicago-area facility and barred local EPA staff from conducting inspections at EtO facilities unless requested by state agencies. ZIMMER BIOMET GETS EXPANDED ROSA 510(K) — Zimmer Biomet announced Tuesday it gained FDA clearance for its Rosa Partial Knee System for robotically assisted, partial-knee replacement surgeries. | | | Trade associations for brand drug manufacturers, physicians and hospitals are among the top spenders on lobbying in the first quarter of 2021, POLITICO’s Caitlin Oprysko reports. The top five: — U.S. Chamber of Commerce: $17.2 million (versus $22.3 million in Q4 2020 and $15.8 million in Q1 2020).
— PhRMA: $8.5 million (versus $5.1 million in Q4 2020 and $9 million in Q1 2020).
— American Medical Association: $6.4 million (versus $3.9 million in Q4 2020 and $6.6 million in Q1 2020).
— Raytheon: $5.3 million (versus $2.1 million in Q4 2020 and $5 million in Q1 2020)
— American Hospital Association: $4.8 million (versus $4.5 million in Q4 2020 and $5.9 million in Q1 2020) | | | |   | | | | | | MEDICAL DEVICE MAKER FILES COMPLAINT OVER APPLE WATCH — Health technology company AliveCor filed a complaint with the U.S. International Trade Commission on Tuesday alleging that the Apple Watch infringes on three of its patents related to personal electrocardiogram technology and heart monitoring. The company had previously filed a federal lawsuit against Apple in December 2020 over the same patents. | | | DIVERSITY (STILL) LAGS IN CLINICAL TRIALS — A pair of studies published in the Journal of the American Medical Association this week adds to overwhelming evidence that clinical trials do not accurately represent the diversity of Americans. The first paper, which examined racial and ethnic representation in 31 clinical trials of ophthalmology drugs between 2000 and 2020, showed “meaningful improvement” in the percentage of Black, Asian and Hispanic or Latinx enrollment. But the authors caution that those gains still lag U.S. demographic trends. A second analysis reviewed 125 studies of hearing-loss management in adults and found that just 16, or 12.8 percent, reported the race or ethnicity of participants — compared to 88, or 70.4 percent, that included data on volunteers’ sex. COVID-19 DRUG HUNT CONTINUES — The National Institutes of Health has launched a pair of clinical trials to bolster the medicine cabinet for Covid-19. One Phase II/III study will test a polyclonal antibody developed by SAB Biotherapeutics in people with mild to moderate disease. The SAB antibody cocktail was better than convalescent plasma at neutralizing SARS-CoV-2 in pre-clinical experiments. The agency also has launched a trial comparing two drugs — remdesivir, also known as Veklury, and aviptadeil acetate, or Zyesami — alone and in combination as treatments for patients with life-threatening cases of Covid-19. | | | Friday: CDC’s Advisory Committee on Immunization Practices meets to discuss J&J’s coronavirus vaccine at 11 a.m. EST. Read the draft agenda. Wednesday: The House Energy and Commerce Health Subcommittee holds a hearing on Covid-19 long haulers at 11 a.m. EST. The House Ways and Means Health Subcommittee holds a hearing on the future of telehealth at 2 p.m. EST. | | | FLORIDA HOUSE PASSES BILL TO CONTINUE LAWSUIT AGAINST OPIOID MAKER — Florida’s House passed legislation that state Attorney General Ashley Moody needs to continue a lawsuit against some of the nation’s largest opioid manufacturers, POLITICO Pro’s Matt Dixon reports. The House Appropriations Committee held an impromptu meeting after the bill was stalled with less than two weeks left in session, in a nod to its importance. The bill allows Moody’s office to continue using the Prescription Drug Monitoring Program database, which tracks controlled substance prescriptions, in active litigation, including the trial she’s preparing. | | | EU PREPPING LEGAL CASE AGAINST ASTRAZENECA — The European Commission is getting ready to launch legal proceedings against vaccine producer AstraZeneca, POLITICO EU’s Jillian Deustch and Jacopo Barigazzi report. A majority of EU countries said they would support suing the company on its massive under-delivery of vaccine doses when the Commission raised the matter at a meeting of EU ambassadors Wednesday. However, about a half-dozen countries did raise concerns about launching such a lawsuit, including that it wouldn’t guarantee more doses. Some ambassadors also warned that a lawsuit would further diminish trust in the vaccine and sully the image of AstraZeneca. A diplomat said the Commission still understandably wants to hit back at the vaccine producer over the delivery shortfalls. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA outlines new pathway for “pooled” Covid testing — The FDA this week unveiled details about a new pathway intended to support the pooled testing of asymptomatic samples (i.e., samples obtained from a patient not suspected to have Covid-19). Pooling is the practice of testing multiple samples at once. According to the FDA, it will permit developers with a molecular diagnostic that is already authorized for use with nasal swabs in a high-complexity laboratory to pool samples as long as they comply with some specific requirements. FDA also this week expressed concern about the use of saliva samples for Covid-19 testing, explaining that the agency is “cautious” and in some cases has seen a “significant difference” in performance between saliva-based tests compared to swab-based tests. AgencyIQ has a full explanation of the new policy and FDA’s concerns. A steady quarter for new generic drug approvals — The FDA’s Office of Generic Drugs approved 197 generic drugs during the first quarter of the calendar year, a number similar to previous quarters, according to a review by AgencyIQ . One area of potential concern for industry may be the flagging number of new generic drug submissions. In 2020, the FDA received an average of 65 generic drug submissions each month, compared to 94 in 2017. According to AgencyIQ’s review, FDA had fewer generic drug applications under review in Q1 than any other quarter since at least 2018. The decline could negatively affect the availability of drug competition and, as a result, drug pricing. | | | A year after a Connecticut company was awarded federal loans and contracts worth up to $1.3 billion to supply a syringe for the Covid-19 vaccine, none have been made and the factory remains unbuilt, NBC News reports. Biogen CEO Michel Vounatsos orders full speed ahead on preparing to launch a controversial drug to treat Alzheimer’s, called aducanumab, as an FDA decision looms, Endpoints News reports. FDA issued six conflict-of-interest waivers for the Oncologic Drugs Advisory Committee’s panel to consider whether indications for three immunotherapies should be withdrawn after failed clinical outcomes studies, Pink Sheet reports. Costco has partnered with Navitus Health Solutions LLC, a small pharmacy benefit manager that offers a fee-based model, and both say the investment will accelerate their growth, Bloomberg News reports. | | | FDA announced a public workshop on model informed drug development approaches for immunogenicity assessments on June 9. Sen. Jeff Merkley (D-Ore.) and Rep. Peter Welch (D-Vt.) introduced the “End Price Gouging for Medications Act,” which seeks to establish reference pricing for prescription drugs using prices in Japan, Germany, the United Kingdom, France, Italy, Canada, Australia, Spain, the Netherlands, Switzerland and Sweden. Sens. Elizabeth Warren (D-Mass.) and Marco Rubio (R-Fla.) introduced the "U.S. Pharmaceutical Supply Chain Review Act," which would require a government study examining the impact of foreign direct investment in the U.S. drug industry. | | | | A message from Viatris: VIATRIS™ is a new kind of healthcare company, committed to providing access to medicines by tackling policy barriers to healthier lives, building on our unique capabilities to advance holistic health solutions, and working with key stakeholders to achieve better health in the communities we serve. Formed in 2020 through the combination of Mylan and Upjohn, Viatris brings together best-in-class scientific, manufacturing and distribution expertise with a future-focused commitment to policy solutions to deliver quality medicines to patients when and where they need them. Securing stable access to medicine for current and future patients can only be achieved through policy dialogue and collaboration. We are committed to bridging traditional divides in search of solutions. Learn more at Viatris.com. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
